NCT00396032已完成3 期
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis Catheters
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- Percentage of Subjects Who Had Treatment Success With Respect to Blood Flow Rate (BFR) at Visit 1
研究概览
简要总结
This was a Phase III, randomized, double-blind, placebo-controlled study conducted at 37 centers in the United States. 150 subjects ≥ 16 years of age who required hemodialysis (HD) and had a dysfunctional HD catheter were enrolled in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically stable, in the opinion of the investigator
- •Use of a cuffed, tunneled HD catheter
- •HD prescribed at a BFR of ≥300 mL/min
- •Baseline BFR (at any time during the first 60 minutes of HD) of <300 mL/min at an associated pre-pump negative arterial pressure in the range between and including -240 mmHg and -280 mmHg
- •Baseline BFR (at any time during the first 60 minutes of HD) at least 25 mL/min below the prescribed BFR
- •Demonstrated BFR of ≥300 mL/min (using catheter lines in the customary direction) at an arterial pressure in the range of 0 to -280 mmHg in at least one HD session in the 14 days prior to Visit 1
- •Anticipated use of the same catheter for at least four consecutive HD sessions, on the same type and model of HD apparatus
- •Able to have fluids infused at the volume necessary to instill study drug into the HD catheter
排除标准
- •HD catheter with sustainable BFR of ≥300 mL/min following subject repositioning
- •HD catheter inserted <2 days prior to screening
- •Evidence of a mechanical, non-thrombotic cause of HD catheter dysfunction (e.g., kink in the catheter or suture constricting the catheter) or dysfunction caused by known fibrin sheath
- •Use of an implantable port
- •HD catheter that is internally coated with any therapeutic agent (e.g., the Decathlon™ Gold catheter)
- •Anticipated use of catheter for any other type of diagnostic or therapeutic procedure (i.e., other than HD) during study drug treatment
- •Previously treated in this study or any tenecteplase catheter clearance trial
- •Use of any investigational drug or therapy (defined as any drug or therapy that is not FDA approved) within 28 days prior to screening
- •Use of a fibrinolytic agent (e.g., alteplase, tenecteplase, reteplase, or urokinase) within 7 days prior to Visit 1
- •Known to be pregnant or breastfeeding at screening or at Visit 1
- •Known bacteremia or known or suspected infection in the HD catheter
- •Known history of any of the following: intracranial hemorrhage (within the previous 3 years), intracranial aneurysm, or arteriovenous malformation
- •Use of heparin (unfractionated or low molecular weight) or other anticoagulants (e.g., for the treatment of heparin-induced thrombocytopenia) within 24 hours prior to Visit 1, except for heparin used only during HD or for prophylaxis (e.g., heparin lock or deep vein thrombosis prophylaxis)
- •Subjects treated with warfarin only: international normalized ratio (INR) >3.0 within 7 days prior to Visit 1, or a target INR range that allows for an INR >3.0 A laboratory test to confirm the INR must have been performed within 7 days prior to Visit
- •Initiation of or increase in dose of Plavix® (clopidogrel bisulfate) within 7 days prior to Visit 1
- •Hemoglobin ≥12.0 g/dL if on an erythropoiesis-stimulating agent (e.g., darbepoetin or erythropoietin) and the dose of the erythropoiesis-stimulating agent has not been held or reduced per institutional policy
- •At high risk for bleeding events or embolic complications (i.e., recent pulmonary embolus, deep vein thrombosis, endarterectomy, or clinically significant right-to-left shunt) in the opinion of the investigator, or with known condition for which bleeding constitutes a significant hazard
- •BFR of <300 mL/min because of symptomatic hypotension
- •Uncontrolled hypertension in the opinion of the investigator
- •Known hypersensitivity to tenecteplase or any component of the formulation
研究组 & 干预措施
1
Experimental
干预措施: tenecteplase (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Percentage of Subjects Who Had Treatment Success With Respect to Blood Flow Rate (BFR) at Visit 1
时间窗: Visit 1 of HD treatment
Treatment success is defined as BFR of ≥300 mL/min and an increase from baseline BFR of ≥25 mL/min at an associated target arterial pressure in the range of 0 to -280 mmHg 30 (±10) minutes prior to the end of HD and at the end of HD.
Incidence of Targeted Adverse Events (AEs) From Initial Study Drug Administration Through the Start of Visit 2
时间窗: Visits 1 and 2 of consecutive HD treatments
Targeted AEs were intracranial hemorrhages (ICHs), major bleeding, embolic events, thrombosis, catheter-related bloodstream infections (CRBSIs), and catheter related complications
次要结局
- Change in BFR From Baseline to the End of HD at Visit 1(Visit 1 of HD treatment)
- Percentage of Subjects Who Had Treatment Success With Respect to BFR at Visit 2 (MITT Population With Extended Dwell Tenecteplase at Visit 1)(Visit 2 of consecutive HD treatments)
- Percentage of Subjects Who Had Treatment Success With Respect to BFR at Visit 2 (MITT Population With Open-label Tenecteplase at Visit 2)(Visit 2 of consecutive HD treatments)
研究者
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